Vigilance Workbench Platform
The Vigilance Workbench signal detection platform spans the full spectrum of the signal management process to ensure all potential signals are tracked with clear prioritization. Robust data integration and functionality enables analysis of aggregate data from multiple adverse event datasets, supported by configurable planning and workflow capabilities.
Safety and Pharmacovigilance Operations
Qinecsa provides complete and compliant safety and pharmacovigilance frameworks to support clinical and commercial products.
Global Medical Information Call Center
Qinecsa provides industry-leading medical and safety call center services led by our team of highly experienced specialists. Our teams provide support covering a diverse range of therapeutic areas. A multi-channel technology enables our team to accept medical information, adverse event, and product quality calls in a variety of languages across the globe.
Fit-for-future sourcing for pharmacovigilance: Embracing Change for Success
Author: Humaira Qureshi, President of Qinecsa Solutions The pharmacovigilance industry is in an unprecedented era of change. PV teams are experiencing year-on-year increases in case volumes, driven in part by increased awareness and reporting by patients. Regulatory agencies are embracing the opportunities provided by innovation and technology, and the rise in methods and formats to […]
Compliant drug safety framework for early phase clinical trials
A biotech had successfully completed Phase I clinical trials and was rapidly progressing into Phase II. Serious adverse event (SAE) volume was expected to significantly increase and therefore associated workload could not be managed in-house. Qinecsa established a compliant and robust drug safety framework in line with budget and quality expectations to manage increased case […]
Cost-effective drug safety systems and solutions
A small pharma client with limited budget had several clinical compounds in Phase I and II, and one globally approved commercial product. They required robust processes for the evaluation of single and aggregate data to strengthen stakeholder review and documentation management associated with serious adverse events (SAEs).
Developing a robust drug safety framework
A small biotech with a healthy development pipeline had no internal pharmacovigilance expertise. They required a compliant drug safety framework to support safety data collection, evaluation, and dissemination during clinical trials. Qinecsa established a simple, compliant drug safety framework, including a suite of policies and procedures in line with relevant legislation, to support collection, evaluation, […]
Transforming data into decisions
Dr Andrew Rut recently presented at the PV Legal Forum in Chicago on the importance of collecting and analyzing holistic safety data in order to make good decisions for individual patients needing treatments. Disconnected systems lead to gaps and errors in the pharmacovigilance process: There is a lack of information at market authorization as clinical […]
Increasing Medical Information Call Center compliance and efficiency
A specialty pharma company were experiencing complaints regarding their existing Medical Information Call Center (MICC) due to a high call abandon rate. Qinecsa provided Medical Information Call Center services in eight languages to support global 24/7/365 coverage, ensuring sustained quality, compliance, and timeliness.
Qinecsa pharmacovigilance consulting guide
Pharmacovigilance consulting is essential throughout the entire lifecycle of both commercial and clinical products. At Qinecsa, a company with a strong focus and heritage on pharmacovigilance consulting, with years of successful safety services delivery enhanced by our innovative technologies, we are a proven, trusted partner to the life science industry. We have successfully helped clients […]
